Status:
COMPLETED
ID HBV Vaccination With Imiquimod in OBI
Lead Sponsor:
The University of Hong Kong
Conditions:
Hepatitis B
Eligibility:
All Genders
27+ years
Phase:
PHASE2
PHASE3
Brief Summary
During the course of chronic hepatitis B infection, patients may undergo hepatitis B surface antigen (HBsAg) seroclearance, resulting in undetectable circulating HBsAg. With the advance of sensitive n...
Detailed Description
This randomized double-blind placebo-controlled trial will compare the safety, immunogenicity and clinical efficacy of Sci-B-Vac™ with topical ointment pretreatment among 5 groups. Group 1: Intraderma...
Eligibility Criteria
Inclusion
- Subjects recruited have to be aged ≥27 years (born before the universal hepatitis B immunization program for newborns introduced in Hong Kong in 1988), with documentation of loss of HBsAg without anti-HBs production during follow-up of the chronic hepatitis B infection in our clinics in Queen Mary Hospital. These patients should have normal liver function tests.
- Subjects have to give written informed consent.
- Subjects must be available to complete the study and comply with study procedures.
- Subjects are willing to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
Exclusion
- Subjects with a history or any illness that might interfere with the results of the study or participation in the study may pose additional risk to the subjects.
- Subjects have a recent history (documented, confirmed or suspected) of a flu-like disease within a week of vaccination.
- Subjects have a known allergy to components of the study vaccine Sci-B-Vac™.
- Subjects have a positive urine or serum pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding.
- Subjects have an active neoplastic disease or a history of any hematologic malignancy.
- Subjects have known chronic active hepatitis C (anti-HCV+ve), autoimmune hepatitis or cirrhosis.
- Subjects have known active human immunodeficiency virus infection (anti-HIV+ve).
- Subjects have known chronic liver disease due to primary biliary cirrhosis, metabolic or hereditary causes.
- Subjects have received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study.
- Subjects participate in another clinical study during the current study.
- Subjects have axillary temperature ≥38°C or oral temperature ≥38.5°C within 3 days of intended study vaccination
- Subjects have a history of alcohol or drug abuse in the last 5 years.
- Subjects have any condition that the investigator believes may interfere with successful completion of the study.
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03307902
Start Date
October 1 2016
End Date
July 31 2019
Last Update
October 22 2019
Active Locations (1)
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1
University of Hong Kong
Hong Kong, Hong Kong